Ported catheter adapter having combined port and blood control valve with venting

ABSTRACT

A ported catheter adapter having a combined blood control valve and port valve, wherein the combined valve comprises one or more vents that permit the passage of air and prevent the passage of fluids. The one or more vents are located on the outer surface of the valve so as to avoid being overlapped with the pathway of the side port. As such, fluid communication between the side port and the vents is prevented. Various venting configurations are provided. The invention further includes a valve actuator that is advanced through a slit in the membrane of the valve to provide a pathway for fluid to bypass the valve.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 61/929,708, filed Jan. 21, 2014, and entitled PORTED CATHETERADAPTER HAVING COMBINED PORT AND BLOOD CONTROL VALVE WITH VENTING, whichis incorporated herein in its entirety.

BACKGROUND

Intravenous infusion systems are commonly used to access the vasculatureof a patient as part of an infusion therapy procedure. An intravenousinfusion system generally includes a fluid reservoir of IV bag that isconnected to the patient via an intravenous catheter. The catheter iscommonly coupled to a catheter adapter having a Luer-lock connector, orother connector-type for coupling the catheter adapter to a syringe, asection of intravenous tubing, or some other external Luer device. Fluidfrom the IV bag flow into the patient via the catheter adapter and theintravenous catheter.

In some instances, the catheter adapter further includes a blood controlvalve that is positioned within a fluid pathway running though thecatheter adapter. The blood control valve divides the fluid pathway orlumen into proximal and distal chambers, and allows selective flow offluid through the fluid pathway. For example, the blood control valvemay include a slit that may be bypassed when an external Luer device iscoupled to the catheter adapter and directly engaging the valve. Uponremoving the external Luer device, the slit is closed to prevent bloodfrom leaking out of the catheter adapter.

A catheter adapter may further include a valve actuator that iscontacted by an external or secondary infusion device, such as a Luerdevice, and advanced through the slit of the valve. The valve actuatoris generally advanced through the valve to provide a temporary pathwaythrough the valve. Upon removal of the secondary infusion device, theresilient nature of the valve backs the valve actuator out of the valveslit.

In some instances, the catheter adapter further comprises a side portwhereby to inject a fluid directly into the inner lumen of the catheteradapter while the catheter adapter is coupled to a separate infusiondevice, such as a section of intravenous tubing. The catheter adapterfurther comprises a port valve that is positioned to form a fluid-tightseal with a pathway of the side port to prevent fluids within the lumenof the catheter adapter from leaking out of the side port. When a fluidis injected through the side port, the port valve is temporarilydeformed by the fluid pressure of the injected fluid, thereby providinga gap through which the injected fluid is permitted to flow into thelumen of the catheter adapter. Following the injection, the port valveis restored to its original conformation, there again forming afluid-tight seal.

Thus, while systems and methods currently exist to simultaneouslycontrol blood flow and allow a fluid to be injected via a side port,challenges still remain. Accordingly, it would be an improvement in theart to augment or replace current techniques with the system and methodsdiscussed herein.

BRIEF SUMMARY OF THE INVENTION

The present invention has been developed in response to problems andneeds in the art that have not yet been fully resolved by currentlyavailable systems and methods. Thus, these systems and methods aredeveloped to provide a ported catheter adapter having a combined portand blood control valve with venting. Thus, the systems and methods ofthe present invention provide an infusion device having a single valvethat control fluid and air flow through the lumen of the ported catheteradapter. The present invention further comprises a valve actuator havingvarious features for retaining the valve actuator within the lumen ofthe ported catheter adapter and preventing over-insertion of the valveactuator through the membrane of the valve.

In some implementations, a ported catheter assembly is providedcomprising a catheter adapter having a proximal end, a distal end and alumen extending therebetween, the catheter adapter further comprising aside port forming a pathway through a sidewall of the catheter adapterand in communication with the lumen. The catheter assembly furthercomprises a combined port and blood control valve disposed within thelumen and dividing the lumen into a proximal chamber and a distalchamber. The valve comprises a body having a surface that forms afluid-tight, defeatable seal with the pathway of the side port. When afluid is injected into the side port, the body of the valve istemporarily deformed, thereby providing a gap between the outer surfaceof the valve and the inner surface of the ported catheter adapter. Thefluid from the side port flows through this gap and into the proximalchamber of the ported catheter adapter. Following the injection, thebody of the valve resumes its initial conformation, therebyreestablishing the fluid-tight seal against the pathway of the sideport.

In some instances, the device further includes a valve actuator havingan outer diameter and disposed within the proximal chamber and having abase, a tip and a body extending therebetween. The tip is positionedproximate to the membrane of the valve and the base is positionedproximate to the proximal end of the catheter adapter. The catheterassembly further comprises an actuator retention tab having an outerdiameter and being positioned on an outer surface of the valve actuatorbody.

The valve generally comprises a flexible tube having an outer diameterthat is approximately the same size as an inner diameter of the lumen,whereby the valve is retained within the lumen by an interference fit.The proximal end of the catheter adapter further comprises and openingthrough which a separate device may be inserted to contact the base ofthe valve actuator and advance the tip of the valve actuator through aslit in the membrane of the valve. In some instances, the valve actuatorcomprises a plurality of windows or vents that are provided to permitfluid to flow in and out of an inner lumen of the valve actuator.

The valve further comprises a plurality of vents forming horizontalchannels on the outer surface of the valve. These vents comprisecross-section areas that are selected to permit the passage of air whilepreventing passage of fluids. The vents are positioned on the outersurface of the valve so as to prevent the vents from overlapping thepathway of the side port. Thus, fluid that is injected into the innerlumen of the ported catheter adapter is prevented from entering thevents, and air within the vents is prevented from exiting the portedcatheter adapter via the pathway and the side port.

In some instances, truncated vents are provided having distal openingsin fluid communication with the distal chamber, and proximal ends thatare in fluid communication with a vent ring. The vent ring forms asemi-annular channel in the outer surface of the valve and comprises oneor more venting holes providing a pathway through the sidewall of thevalve. Thus, air within the distal chamber passes into the proximalchamber by flowing through the truncated vents, into the vent ring andthrough the venting hole.

In some instances, an annular vent ring is provided and used incombination with truncated vents that are positioned around the entirecircumference of the valve. For these embodiments, the annular vent ringis positioned such that is does not overlap the pathway of the sideport. In some implementations, a distance is provided between thepathway of the side port and the annular vent ring, wherein thisdistance insures that the proximal body portion of the valve may deformto allow passage of fluid being injected through the side port, withoutallowing fluid communication between the annular vent ring and thepathway of the side port.

The present invention further includes various embodiments comprisingone or more vents formed in the inner surface of the ported catheteradapter and interposed between the outer surface of the valve and thecatheter adapter, wherein the one or more vents provide a functionsimilar to those discussed in connection with the vents provided on theouter surface of the valve.

These and other features and advantages of the present invention may beincorporated into certain embodiments of the invention and will becomemore fully apparent from the following description and appended claims,or may be learned by the practice of the invention as set forthhereinafter. The present invention does not require that all theadvantageous features and all the advantages described herein beincorporated into every embodiment of the invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In order that the manner in which the above-recited and other featuresand advantages of the invention are obtained will be readily understood,a more particular description of the invention briefly described abovewill be rendered by reference to specific embodiments thereof that areillustrated in the appended drawings. These drawings depict only typicalembodiments of the invention and are not therefore to be considered tolimit the scope of the invention.

FIG. 1 is a perspective view of a ported infusion therapy device inaccordance with a representative embodiment of the present invention.

FIG. 2A is a cross-section, side view of a ported catheter adapterhaving a combined port and blood control valve, a valve actuator, and anactuator retention tab, and being shown prior to activation inaccordance with a representative embodiment of the present invention.

FIG. 2B is a cross-section, side view of a ported catheter adapterhaving a combined port and blood control valve, a valve actuator, and anactuator retention tab, and being shown following activation and a fluidbeing injected via the side port in accordance with a representativeembodiment of the present invention.

FIG. 2C is a cross-section, side view of a ported catheter adapterhaving a combined port and blood control valve, a valve actuator, and anactuator retention tab, and being shown following activation and a fluidbeing infused via the proximal opening in accordance with arepresentative embodiment of the present invention.

FIG. 3, shown in parts A-C, shows various cross-section end views of aported catheter adapter having a plurality of vents in accordance withvarious representative embodiments of the present invention.

FIG. 4A shows a partial cross-section perspective side view of a portedcatheter adapter having a vented valve comprising a plurality ofhorizontal vents in accordance with a representative embodiment of thepresent invention.

FIG. 4B shows a partial cross-section perspective side view of a portedcatheter adapter having a vented valve comprising a plurality ofhorizontal vents, a vent ring and a venting hole in accordance with arepresentative embodiment of the present invention.

FIG. 5 shows a cross-section top view of a vented valve in a portedcatheter adapter in accordance with a representative embodiment of thepresent invention.

FIG. 6 shows a cross-section bottom view of the vented valve and portedcatheter adapter of FIG. 5 in accordance with a representativeembodiment of the present invention.

FIG. 7 shows a cross-section top view of a vented valve in a portedcatheter adapter in accordance with a representative embodiment of thepresent invention.

FIG. 8, shown in parts A and B, shows a cross-section side view of avented valve in a ported catheter adapter prior to and while beinginjected with a fluid through the side port in accordance with arepresentative embodiment of the present invention.

FIG. 9 shows a cross-section side view of a valve positioned in acatheter adapter having a plurality of vents and being injected with afluid through the side port of the catheter adapter in accordance with arepresentative embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiments of the present invention can beunderstood by reference to the drawings, wherein like reference numbersindicate identical or functionally similar elements. It will be readilyunderstood that the components of the present invention, as generallydescribed and illustrated in the figures herein, could be arranged anddesigned in a wide variety of different configurations. Thus, thefollowing more detailed description, as represented in the figures, isnot intended to limit the scope of the invention as claimed, but ismerely representative of presently preferred embodiments of theinvention.

Moreover, the Figures may show simplified or partial views, and thedimensions of elements in the Figures may be exaggerated or otherwisenot in proportion for clarity. In addition, the singular forms “a,”“an,” and “the” include plural referents unless the context clearlydictates otherwise. Thus, for example, reference to a terminal includesreference to one or more terminals. In addition, where reference is madeto a list of elements (e.g., elements a, b, c), such reference isintended to include any one of the listed elements by itself, anycombination of less than all of the listed elements, and/or acombination of all of the listed elements.

The term “substantially” means that the recited characteristic,parameter, or value need not be achieved exactly, but that deviations orvariations, including for example, tolerances, measurement error,measurement accuracy limitations and other factors known to those ofskill in the art, may occur in amounts that do not preclude the effectthe characteristic was intended to provide.

As used herein, the term “proximal”, “top”, “up” or “upwardly” refers toa location on the device that is closest to the clinician using thedevice and farthest from the patient in connection with whom the deviceis used when the device is used in its normal operation. Conversely, theterm “distal”, “bottom”, “down” or “downwardly” refers to a location onthe device that is farthest from the clinician using the device andclosest to the patient in connection with whom the device is used whenthe device is used in its normal operation.

As used herein, the term “in” or “inwardly” refers to a location withrespect to the device that, during normal use, is toward the inside ofthe device. Conversely, as used herein, the term “out” or “outwardly”refers to a location with respect to the device that, during normal use,is toward the outside of the device.

Referring now to FIG. 1, a ported infusion therapy device 10 is shown.Device 10 generally comprises various features and elements to enablesubcutaneous or intravenous infusion of a fluid or medicament into apatient. In some instances, device 10 further comprises feature toenable removal of a fluid from a patient, such as blood.

Device 10 generally comprises a ported catheter adapter 20 having aproximal end 22, a distal end 24 and a lumen 26 extending therebetween.In some instances, catheter adapter 20 further comprises a side port 30forming a pathway through a sidewall of catheter adapter 20 and incommunication with lumen 26. A valve 40 (shown in FIGS. 2-7) is placedwithin lumen 26 so as to provide a defeatable barrier to control theflow of fluids through lumen 26. In some instances, valve 40 comprises amembrane that divides lumen 26 into a proximal chamber and a distalchamber, as discussed in detail, below. In some instances, the membranecomprises a slit that may be opened by inserting a device through theslit, such as a valve actuator. In other instances, the slit may betemporarily biased into an opened position by inserting a fluid intoproximal end 22 of adapter 20. Upon removal of the valve actuator fromthe slit, or as the fluid pressure decreases within lumen 26, theresilient nature of the membrane causes the slit to close, thereby onceagain preventing passage of fluid through lumen 26.

Valve 40 further comprises a tubular body that provides a barrierbetween side port 30 and lumen 26. Valve 40 generally comprises aresilient, flexible material that is easily deformed when fluid isintroduced to port 30 via a syringe or other compatible device. Forexample, in some instances valve 40 comprises silicone,polytetrafluoroethylene, or a similar polymer material. Upon deformationof valve 40, fluid from the syringe is permitted to bypass the deformedvalve and flow into lumen 26. As the fluid pressure decreases, theresilient nature of the valve's material causes valve 40 to restore itsoriginal shape, thereby once again blocking the fluid pathway.

Device 10 further comprises a catheter 12 that is coupled to distal end24 and which is configured for insertion into a patient. In someinstances, catheter 12 comprises a rigid plastic or metallic materialhaving a sharpened distal end that can pierce the patient's skin andgain access to the vasculature or subcutaneous tissues of the patient.In other instance, catheter 12 comprises a flexible material having aninner diameter through which an introducer needle 16 is inserted.Introducer needle 16 comprises a rigid metallic material having asharpened distal end that extends through catheter 12 and is exposedbeyond the tip 14 of catheter 12. The introducer needle is capable ofpiercing the skin to provide access to the vasculature or subcutaneoustissues of the patient. Once access is obtained, tip 14 of catheter 12is inserted through the newly formed opening and into the desiredlocation within the patient. Introducer needle 16 is then withdrawn fromdevice 10, and catheter 12 is left disposed within the patient.

Proximal end 22 further comprises an opening 28 for receiving asecondary infusion therapy device 50, such as a syringe or intravenousfluid line. In some instances, proximal end 22 comprises a set ofthreads 29 configured to threadedly receive the secondary device 50 in asecure manner. Opening 28 may further comprise a tapered opening wherebyto receive secondary device 50 via an interference or friction fit.Proximal end 22 and opening 28 may alternatively comprises varioussurfaces and other features to enable coupling to a needle hub, adiagnostic device, and other suitable infusion therapy equipment.

Referring now to FIG. 2A, a cross-section side view catheter adapter 20is shown in an inactivated state. Catheter adapter 20 further comprisesa blood control valve 40 that is disposed within lumen 26, therebydividing lumen 26 into proximal 70 and distal 80 fluid chambers. In someinstances, the inner surface of adapter 20 comprises an annular recessor groove 72 having a length that is approximately equal to the lengthof blood control valve 40. The inner diameter of groove 72 isapproximately equal to the outer diameter of valve 40. Valve 40 is thusfitted or seated into groove 72 to provide an assembled device.Generally, valve 40 is seated into groove 72 in a secure manner toprevent unintended passage of liquids between the outer surface of valve40 and the inner surface of adapter 20 or groove 72. In some instances,the inner diameter of groove 72 is slightly smaller than the outerdiameter of valve 40, thereby providing an interference fit of valve 40within groove 72. In other instances, valve 40 is retained within groove72 via an adhesive or an epoxy material.

Valve 40 may comprise any shape or structure that is compatible with theteachings of the instant invention. In some instances, valve 40comprises a cylindrical structure having a proximal opening 42, a distalmembrane 44 comprising a slit 46, and a body 48 extending therebetween.Slit 46 comprises a sealed interface which provides a fluid-tight seal,thereby preventing fluid from bypassing valve 40.

Valve 40 comprises a flexible, resilient material that may beselectively deformed to open slit 46 to permit passage of fluids. Forexample, in some embodiments increased fluid pressure within proximalfluid chamber 70 will result in valve 40 being temporarily deformed,thereby permitting fluid within proximal chamber 70 to bypass valve 40through slit 46 and flow into distal fluid chamber 80 of lumen 26. Inother instances, slit 46 is biased into an opened position bytemporarily or permanently inserting an object through slit 46, such asa valve actuator 90.

Body 48 of valve 40 is positioned within lumen 26 so as to provide afluid-tight, defeatable barrier between proximal chamber 70 and pathway32 of side port 30. Upon injecting a fluid 100 from a secondary infusiondevice 110 into side port 30 and through pathway 32, body 48 istemporarily deformed to provide a gap 50 between groove 72 and the outersurface of valve 40. Fluid 100 is thus permitted to flow through gap 50and into proximal chamber, as shown in FIG. 2B. Upon removal ofsecondary infusion device 110 from side port 30, the resilient nature ofvalve 40 causes body 48 to resume its original conformation, therebyonce again establishing a fluid-tight seal between body 72 and pathway32, and preventing subsequent flow of fluids through pathway 32, asshown in FIGS. 2A and 2C.

Referring again to FIG. 2A, device 10 further comprises a valve actuator90 that is disposed within proximal chamber 70. Valve actuator 90 maycomprise any shape, structure or configuration that is compatible withany of the various representative embodiments or teachings of theinvention described herein. In some instances, valve actuator comprisesa base 92, a tip 94, and a body 96 extending therebetween. Valveactuator 90 further comprises a hollow interior through which a fluid100 may pass. In some instances, body 96 comprises one or more fluidvents or windows 97 forming a fluid pathway through a sidewall of thevalve actuator 90 and in communication with lumen 26, thereby providingdiverse flow patterns for a fluid passing through lumen 26 and valveactuator 90. Thus, a fluid within the hollow interior of valve actuator90 may pass through the one or more windows 97 and into lumen 26.

Base 92 is generally positioned proximate to opening 28 of catheteradapter 20, thereby being accessible to a secondary infusion therapydevice 120, such as a male Luer connector coupled to a section ofintravenous tubing 122. Tip 94 is positioned proximate to membrane 44and slit 46. Tip 94 is advanced through slit 46 as base 92 is pushed indistal direction 100 as secondary infusion therapy device 120 isinserted through opening 28 and threadedly secured to proximal end 22,as shown in FIGS. 2B and 2C. Upon removal of secondary device 120, theresilient nature of valve 40 causes membrane 44 to restore its originalformation, thereby backing tip 94 out of slit 46, and sliding valveactuator 90 in proximal direction 102, thereby restoring the fluid-tightseal of slit 46, as shown in FIG. 2A.

With continued reference to FIGS. 2A-2C, valve actuator 90 may furthercomprise an actuator retention tab 98. Retention tab 98 generallycomprises an annular protrusion or other feature on the outer surface ofvalve actuator 90 that interacts with a proximal groove 79 formed on theinner surface of adapter 20 at a position between proximal opening 42 ofvalve 40 and proximal opening 28 of adapter 20. The interaction betweenretention tab 98 and proximal groove 79 limits the proximal and distalmovement of valve actuator 90 within lumen 26. In some instances,retention tab 98 comprises an outer diameter that is greater than theouter diameter of body 96 and less than an inner diameter of proximalgroove 79, thereby permitting retention tab 98 to slide freely withinproximal groove 79. The maximum distance that valve actuator 90 ispermitted to travel within lumen 26 (in proximal and distal directions)is thus limited by the width of proximal groove 79.

In some embodiments, the width and placement of proximal groove 79 isselected such that base 92 is prevented from exiting proximal opening 28of adapter 20. The width and placement of proximal groove 79 is furtherselected to ensure tip 94 is advanced through slit 46 to a desireddepth. For example, in some instances it may be desirable to preventover-insertion of tip 94 through slit 46. Over-insertion may beunderstood to describe a penetration depth of tip 94 into slit 46 wherevalve 40 is incapable of backing tip 94 out of slit 46 when secondaryinfusion device 120 is removed from opening 28. Over-insertion of tip 94into slit 46 may thus prevent slit 46 from reforming a fluid-tight seal.Accordingly, in some embodiments, the width of proximal groove 79 isselected so that the maximum permitted distal movement of retention clip98 prevents tip 94 from being over-inserted in slit 46.

Similarly, the width and placement of proximal groove 79 may be selectedto ensure that tip 94 of valve actuator 90 is permitted to penetrateslit 16 to a minimum insertion depth. Minimum insertion depth may beunderstood to describe a penetration depth where the surface area of theopening provided in slit 46 is greater than or equal to the surface areaof the opening of tip 94. As such, the minimum insertion depth throughslit 46 provides an opening or fluid pathway through valve 40 that doesnot impede or interfere with the flow of fluid passing through valveactuator 90. Thus, the width and position of proximal groove 79, as wellas the distance between retention ring 98 and tip 94 may be selected toensure proper insertion depth of tip 94 through slit 46.

Prior to activation, tip 94 of valve actuator 90 is positioned adjacentmembrane 44, and base 92 is positioned adjacent opening 28 of adapter20, as shown in FIG. 2A. Further, retention tab 98 is positioned in amaximum, proximal location within proximal groove 79. Upon insertion ofsecondary infusion device 120 into opening 28, base 92 is contacted bydevice 120 and valve actuator 90 is advanced in a distal direction,thereby moving retention tab 98 to a maximum distal position withinproximal groove 79, as shown in FIGS. 2B and 2C. Tip 94 is thus advancedinto membrane 44 and partially inserted through slit 46. In someinstances, tip 94 is over-inserted through slit 46, thereby providing apermanent pathway through membrane 44.

With reference to FIG. 2B, in some instances fluid 100 is introducedinto lumen 26 via pathway 32 of side port 30 from secondary infusiondevice 110. The injected fluid 100 biases body 48 against valve actuator90, thereby providing gap 50 through which fluid 100 flows. Accordingly,in some embodiments the outer diameter of valve actuator 90 is slightlyless than an inner diameter of valve 40, thus allowing valve 40 to betemporarily deformed.

In some preferred embodiments, fluid 100 bypasses valve 40 and entersproximal chamber 70 of lumen 26. Fluid 100 is then intermixed with fluid101 from secondary infusion device 120. The mixed fluids 102 then flowthough valve actuator 90, out of valve 40, and into catheter 12 as partof an infusion therapy. Upon removal of secondary infusion device 110,body 48 returns to its original shape, thereby preventing fluid fromexiting lumen 26 via gap 50 and pathway 32 of side port 30, as shown inFIG. 2C. When the infusion therapy is complete, secondary infusiondevice 120 is removed from proximal end 22, whereupon tip 94 of valveactuator 90 is backed out of membrane 44 as slit 46 returns to itsoriginal, closed position, thereby preventing fluids from flowingbetween proximal and distal chambers 70 and 80, as shown in FIG. 2A.

Some embodiments of the present invention further comprise a vent 130interposed between the outer surface of the valve 40 and an innersurface of the lumen 70 of the catheter adapter 20, as shown in FIGS.3A-9. Vent 130 generally comprises a groove or recess having across-section area that is selected to permit passage of air whilepreventing the passage of fluid. For example, during catheterization itis desirable to minimize pressure buildup in distal chamber 80 due toblood entering the chamber. Increased pressure in distal chamber 80 mayprevent blood from flowing through catheter 12 to provide flashback andindicate proper venous insertion. Accordingly, vents 130 permit airpressure within distal chamber 80 to be transferred to proximal chamber70, thereby providing equalized pressures within the adjacent chambers.

It is also desirable to prevent blood and other fluids from bypassingmembrane 44 through vents 130, thereby preventing undesirable exposureto fluids that may exit proximal opening 28 of catheter adapter 20.Accordingly, in some instances the cross-section area of vents 130 isselected to permit passage of air while preventing passage of fluids.For example, in some instances the cross-section area of vent 130 isselected such that the surface tension of the fluid prevents the fluidfrom entering into, and passing through vents 130.

In some instances, vents 130 comprise horizontal channels that areformed in the inner surface of catheter adapter 20, as shown in FIG. 3A.Vents 130 generally comprise a length that is greater than or equal tothe length of valve 40, whereby air is permitted to bypass valve 40. Inother instances, vents 132 comprise horizontal channels that are formedin the outer surface of valve 40, as shown in FIG. 3B. Further, in someinstances a vent is provided comprising a horizontal channel 130 formedin the inner surface of catheter adapter 20 combined with a horizontalchannel 132 formed on the outer surface of valve 40, wherein thecombined cross-sectional areas of the two channels prevents passage of afluid, as shown in FIG. 3C. In one embodiment, horizontal channel 132comprises a cross-sectional area that is less than a cross-sectionalarea of horizontal channel 130.

Vents 130 are generally located at positions that do not overlap withpathway 32 of side port 30. With reference to FIG. 3A, vent 130 is shownradially spaced from a central axis 33 of pathway 32 by angle θ, whichangle is comprised of θ₁ and θ₂. In some instances, angle θ isapproximately 120°. In other instances, angle θ is from approximately30° to approximately 180°. Further, in some instances angle θ is greaterthan 180°.

Angles θ₁ and θ₂ may be equal angles or may include non-equal angles. Inall instances, angle θ is selected to prevent fluid communicationbetween vents 130 and pathway 32. Accordingly, angle θ prevents a fluidthat is injected into side port 30 and pathway 32 from flowing intovents 130. Conversely, angle θ is selected to prevent air within vent130 from passing into pathway 32 and side port 30.

Referring now to FIG. 4A, a partial cross-section perspective side viewof catheter adapter 20 and valve 40 is shown. In some instances, vents132 comprise horizontal channels formed in the outer surface of valve 40extending the entire length of valve 40. Vents 132 comprise a depth thatis greater than the depth of annular groove 72, such that the proximaland distal openings of vents 132 are exposed to proximal and distalchambers 70 and 80, respectively. In some instances, the thickness ofmembrane 44 adds rigidity to the distal end of valve 40, therebypreventing membrane 44 from collapsing or deforming when a fluid isinjected through side port 30 and pathway 32. Accordingly, the injectedfluid deforms the proximal end of valve 40, thereby displacing the fluidinto proximal chamber 70.

Referring now to FIG. 4B, a partial cross-section perspective side viewof catheter adapter 20 and valve 40 is shown. In some instances valve 40comprises a plurality of vents 132 having a distal opening in fluidcommunication with the distal fluid chamber 80, and further comprising aproximal opening in fluid communication with a vent ring 140. Vent ring140 comprises a semi-annular recess formed in the outer surface of valve40. In some instances, vent ring 140 forms a recessed channel that isperpendicular to vents 132. Vent ring 140 comprises a length that isequal to a radial distance between the topmost vents 132, or between thefirst and last horizontal vent channels. Vent ring 140 intersects eachvent 132 thereby providing fluid communication between each of theindividual vent channels.

Vent ring 140 further comprises one or more venting holes 142 thatprovide fluid communication between vents 132, vent ring 140, andproximal chamber 70. In some instances, venting hole 142 comprises across-section area that is equal to the sum of each of the cross-sectionareas of vents 132. As such, venting hole 142 permits uninterrupted airflow through vents 132. In some instances, vent ring 140 comprises aplurality of venting holes 142, wherein the sum of each of thecross-section areas of the venting holes is equal to, or greater thanthe sum of each of the cross-section areas of vents 132.

Referring now to FIG. 5, a cross-section top view of ported infusiontherapy device 10 is shown. As shown, air 103 travels through vents 132and into vent ring 140. Air 103 within vent ring 140 then passes throughbody 48 via venting holes 142 and into proximal chamber 70. Vents 132,vent ring 140 and venting holes 142 are positioned within the lumen ofcatheter adapter 20 such that these features do not overlap pathway 32,as shown in FIG. 6. Thus, air within vents 132, vent ring 140 andventing holes 142 do not pass into side port 30 or pathway 32.

In some instances, vent 40 comprises a thickened inner sidewall formingan inwardly projecting ring that correlates with vent ring 140, as shownin FIG. 6. In other instances, the thickened portion of the innersidewall further correlates with or partially overlaps pathway 32,thereby adding further resistance to deformation of valve 40 at ventring 140. In some instances, the thickened portion of the inner sidewallcorrelates only with vent ring 140, whereby the portion of the sidewallthat correlates with or overlaps pathway 32 is of a standard thickness.

Referring now to FIG. 7, a cross-section top view of ported infusiontherapy device 10 is shown. In some instances, vent ring 140 comprises aplurality of venting holes 142, and a plurality of vents 132, wherein aseparate venting hole 142 is provided for each vent 132. Venting holes142 may comprise any cross-sectional area that achieved a desired rateof air flow through vents 132. In some instances, venting holes 142comprise a cross-sectional area that is greater than the cross-sectionarea of vents 132. In other instances, venting holes 142 comprise across-sectional area that is approximately equal to the cross-sectionalareas of vents 132, as shown in FIGS. 8A and 8B.

With continued reference to FIGS. 8A and 8B, in some instances vent 40comprises an annular vent ring 141 and a plurality of vents 132 that arepositioned around the entire circumference of valve 40. For theseembodiments, vent ring 141 is positioned between membrane 44 and pathway32, such that vent ring 141 does not overlap with pathway 32. As fluid100 is injected through side port 30, the proximal end of valve 40deforms, thereby directing the injected fluid 100 to flow in a proximaldirection and into the proximal chamber 70. The distance between ventring 141 and pathway 32 prevents fluid 100 from entering vent ring 141and/or vents 132. Further, in some instances vent ring 141 comprises athickened sidewall, thereby providing increased rigidity to this portionof valve 40. The thickened sidewall further prevents this portion ofvalve 40 from deforming when fluid 100 is injected through side port 30.

In other instances, vent 130 comprises one or more horizontal groovesformed in the inner wall surface of catheter adapter 20, as shown inFIG. 9. For these embodiments, the distal opening of vent 130 is influid communication with distal chamber 80, and the proximal opening isin fluid communication with vent ring 141 of valve 40. In someinstances, a secondary vent ring (not shown) is provided on the innersurface of catheter adapter 20, wherein venting holes 142 are notinterconnected via vent ring 141, but rather are aligned with thesecondary vent ring. Thus, air within vents 130 and the secondary ventring is transferred to proximal chamber 70 via venting holes 142.

Venting holes 142 provide pathways through valve 40, thereby providingfluid communication between proximal chamber 70 and distal chamber 80via vents 130 and vent ring 141. In some instances, the cross-sectionarea of vents 130 is greater than the cross-section area of ventingholes 142. In other instances, the cross-section area of vents 130 isthe same or less than the cross-section area of venting holes 142. Vents130 may similarly be used with a semi-annular vent ring 140, asdiscussed previously. Vents 130 may also be used with vents 132, as maybe desired.

One having skill in the art will appreciate that the features discussedherein may equally be implemented in either the outer surface of valve40 or the inner surface of catheter adapter 20, without requiring undueexperimentation. Thus, one having skill in the art may achieve desiredair flow between the proximal and distal chambers 70 and 80 of catheteradapter 20 by any combination of the features and methods discussedherein.

The present invention may be embodied in other specific forms withoutdeparting from its structures, methods, or other essentialcharacteristics as broadly described herein and claimed hereinafter. Thedescribed embodiments are to be considered in all respects only asillustrative, and not restrictive. The scope of the invention is,therefore, indicated by the appended claims, rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

The invention claimed is:
 1. A ported catheter assembly, comprising: acatheter adapter having a proximal end, a distal end and a lumenextending therebetween, the catheter adapter further comprising a sideport forming a pathway through a sidewall of the catheter adapter and incommunication with the lumen; a valve disposed within the lumen andhaving a proximal opening, a distal membrane, and an inner cavityextending therebetween, the valve comprising an outer surface in contactwith an inner surface of the catheter adapter, wherein a portion of theouter surface forms a seal between the lumen and the pathway of the sideport, and wherein the distal membrane divides the lumen into a proximalchamber and a distal chamber; and a vent interposed between the outersurface of the valve and an inner surface of the catheter adapter,wherein the vent comprises a first end proximate the distal chamber anda second end disposed towards a middle portion of the valve, wherein thevent comprises a cross-sectional area that permits the passage of airand prevents the passage of blood.
 2. The ported catheter assembly ofclaim 1, further comprising a valve actuator disposed within theproximal chamber and having a base, a tip and a body extendingtherebetween, the body being at least partially positioned within theinner cavity such that the tip of the valve actuator is positionedproximate to the distal membrane, and the base is positioned proximateto the proximal end of the catheter adapter.
 3. The ported catheterassembly of claim 2, wherein the proximal end of the catheter adapterfurther comprises an opening through which the base of the valveactuator may be accessed.
 4. The ported catheter assembly of claim 2,further comprising an actuator retention tab coupled to an outer surfaceof the valve actuator and positioned within an annular groove formed onan inner surface of the catheter adapter within the proximal chamber. 5.The ported catheter assembly of claim 4, wherein the lumen comprises aminimum diameter, the annular groove comprises a diameter that isgreater than the minimum diameter, and the retention tab comprises anouter diameter that is less than the diameter of the annular groove andgreater than the minimum diameter.
 6. The ported catheter assembly ofclaim 4, wherein the annular groove comprises a first end, a second end,and a length extending therebetween, wherein the retention tab travelswithin the annular groove between the first and second ends to advancethe tip of the valve actuator though a slit in the distal membrane ofthe valve.
 7. The ported catheter assembly of claim 2, wherein the valvemay be defeated to provide a pathway through the distal membrane byadvancing the tip of the valve actuator through a slit in the distalmembrane.
 8. The ported catheter assembly of claim 1, wherein the valvemay be defeated by injecting a fluid through the side port, wherebyfluid pressure from the injected fluid temporarily deforms the body ofthe valve to permit the injected fluid to flow into the proximal chamberof the lumen via the pathway though the sidewall of the catheteradapter.
 9. The ported catheter assembly of claim 1, wherein the ventcomprises at least one of one or more recessed surfaces formed in theouter surface of the valve and one or more recessed surfaces formed inthe inner surface of the catheter adapter.
 10. The ported catheterassembly of claim 1, wherein the second end of the vent is disposeddistal to the pathway through the sidewall of the catheter adapter. 11.The ported catheter assembly of claim 1, wherein the outer surface ofthe valve further comprises an annular recess or a partial annularrecess in fluid communication with the vent and comprising an opening topermit fluid communication between the vent and the inner cavity of thevalve via the annular recess or the partial annular recess.
 12. Theported catheter assembly of claim 11, wherein the annular recess or thepartial annular recess is disposed at the second end of the vent. 13.The ported catheter assembly of claim 1, wherein the cross-sectionalarea of the vent permits the passage of air at a desired flow rate from0.5 ml/min to 3 ml/min.
 14. The ported catheter assembly of claim 1,wherein the cross-sectional area of the vent permits the passage of airat a desired flow rate from 0.1 ml/min to 10 ml/min.
 15. The portedcatheter assembly of claim 1, wherein the valve comprises a flexibletube having an outer diameter that is approximately the same size as aninner diameter of the lumen, whereby the valve is retained within thelumen by an interference fit.
 16. A blood control valve for use in aported catheter adapter, the valve comprising: a flexible tube,comprising: a proximal opening; a distal membrane; an inner cavityextending between the proximal opening and the distal membrane; an outersurface having a diameter that is approximately equal to an innerdiameter of the ported catheter adapter, whereby the valve is configuredto be retained within the catheter adapter via a friction fit, the outersurface further having a length sufficient to form a seal between alumen of the catheter adapter and a pathway of a side port of the portedcatheter adapter, and wherein the distal membrane divides the lumen ofthe ported catheter adapter into a proximal chamber and distal chamber;and a recess formed in the outer surface of the flexible tube, whereinthe recess comprises a first end proximate the distal chamber when thevalve is inserted into the catheter adapter and a second end disposedtowards a middle portion of the flexible tube, wherein the recess has across-sectional area that permits the passage of air and prevents thepassage of blood.
 17. The blood control valve of claim 16, wherein theseal may be selectively defeated by injecting a fluid through the sideport, thereby temporarily permitting the fluid to flow through thepathway of the side port and into the lumen of the catheter adapterthrough a space provided between the outer surface of the flexible tubeand an inner surface of the catheter adapter.
 18. The blood controlvalve of claim 17, wherein the outer surface of the flexible tubefurther comprises a vent ring in fluid communication with the recess andcomprising an opening to permit fluid communication between the ventring and the inner cavity of the flexible tube.